Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries

NCT ID: NCT06571032

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-12-31

Brief Summary

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The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).

The main questions it aims to answer are:

1. Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
2. How can EEG be used to evaluate the condition of patients with severe TBI?

Detailed Description

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Conditions

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Brain Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consicousness improved group

After receiving neuroelectrial stimulation, the patients with severe TBI have the consciousness improvement (CRS-R score is higher than before).

No interventions assigned to this group

Consicousness unimproved group

After receiving neuroelectrial stimulation, the patients with severe TBI have no consciousness improvement (CRS-R score remains the same as before).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 7 days after severe traumatic brain injuries (GCS score 3-8);
* Over 18 years old, regardless of gender;
* The patient's legal representative is informed and voluntarily signs the consent form.

Exclusion Criteria

* Unstable vital signs;
* History of mental disorders or neurodegenerative diseases;
* Uncontrolled epilepsy;
* Severe arrhythmias or patients with implanted cardiac pacemakers;
* Various conditions that interfere with scalp EEG collection;
* Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junfeng Feng

Director of Brain Injury Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junfeng Feng, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiji Weng, Ph.D.

Role: CONTACT

+8613916673435

Facility Contacts

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Junfeng Feng, Ph.D.

Role: primary

+8613611860825

Other Identifiers

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LY2024-007

Identifier Type: -

Identifier Source: org_study_id

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